← Trials/Trial dossier/NCT06186063

AmyBone

UnknownPhase NA

The Role of Amylin in Bone Metabolism

Lead sponsor

Filip Krag Knop

Asset

Pramlintide

Intravenous · Amylin analog

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Healthy volunteers, Type 1 diabetes

Key I/E criteria

•BMI 18.5-27•Healthy volunteers

Primary endpoints

•Relative changes in the plasma levels of C-terminal telopeptide of type I (auc total, auc incremental baseline subtracted, nadir pct change from baseline)•Relative changes in the plasma levels of N-terminal propeptide of type I

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06186063

Org study IDH-22050946

Timeline

Milestones

Study first posted2023-12-29actual

Study start2024-02-12actual

Last update posted2024-02-21actual

Primary completion2024-08-01estimated

Study completion2024-08-01estimated

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Healthy volunteersType 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age60 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

type 1 diabetes:

•Caucasian ethnicity

•Age between 18 and 60 years

•BMI between 18.5 and 27 kg/m2

•Type 1 diabetes (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mmol/mol (<8.5%) and

•Type 1 diabetes duration of 2-20 years

•C-peptide negative (stimulated C-peptide ≤30 pmol/l)

•Treatment with a stable basal-bolus or insulin pump regimen for ≥3 months

•Normal vitamin D (>50 nmol/l)

•Informed consent

Exclusion criteria

type 1 diabetes:

•Anaemia (haemoglobin below normal range)

•Liver disease (ALAT and/or ASAT >2 times normal values) or history of hepatobiliary disorder

•Nephropathy (eGFR <60 ml/min/1,73m2 and/or microalbuminuria)

•Microvascular complications except non-proliferative retinopathy

•Treatment with anti-osteoporosis medication or glucocorticoids

•Fractures within the last 6 months

•For women: currently perimenopausal or postmenopausal

•Diseases affecting calcium metabolism (e.g. hypoparathyroidism, hyperparathyroidism, osteoporosis, vitamin D deficiency and cancer)

•Pregnancy or breastfeeding

•Any physical or psychological condition that the investigator feels would interfere with trial participation

•Treatment with any glucose-lowering drugs beside insulin, treatment with medication against osteoporosis or treatment with any form of glucocorticoids

Inclusion criteria healthy controls:

•Caucasian ethnicity

•Age between 18 and 60 years

•BMI between 18.5 and 27 kg/m2

•Fasting plasma glucose ≤7.0 mmol/l and glycated haemoglobin (HbA1c) <48 mmol/mol

•Normal blood haemoglobin (8.3-10.5 mmol/l (males) and 7.3 - 9.5 mmol/l (females))

•Normal plasma vitamin D (>50 nmol/l)

•Informed consent

Exclusion criteria healthy controls:

•Any form of diabetes (according to World Health Organization criteria)

•Anaemia (haemoglobin below normal range)

•Nephropathy (eGFR <60 ml/min/1,73m2 and/or microalbuminuria)

•Known liver disease and/or alanine transaminase (ALAT) or aspartate transaminase (ASAT) >2 × upper normal limit

•Any fractures within the last 6 months

•For women: currently perimenopausal or postmenopausal

•Diseases affecting calcium metabolism (e.g. hypoparathyroidism, hyperparathyroidism, osteoporosis, vitamin D deficiency and cancer)

•Pregnancy or breastfeeding

•Any condition considered incompatible with participation by the investigators

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Glycemic / diabetes

Safety / tolerability / PK

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Changes in plasma concentrations of insulin.

Time frame:From -15 minutes to 180 minutes

concentration, descriptive

Secondary/protocol endpoint

Changes in plasma concentrations of C-peptide.

Time frame:From -15 minutes to 180 minutes

C-peptide AUC

concentration, descriptive

Secondary/protocol endpoint

Changes in plasma concentrations of glucose.

Time frame:From -15 minutes to 180 minutes

Postprandial glucose

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Changes in plasma concentrations of glucose-dependent insulinotropic polypeptide (GIP).

Time frame:From -15 minutes to 180 minutes

concentration, descriptive

Secondary/protocol endpoint

Changes in plasma concentrations of glucagon-like peptide 1 (GLP-1).

Time frame:From -15 minutes to 180 minutes

concentration, descriptive

Secondary/protocol endpoint

Changes in plasma concentrations of glucagon-like peptide 2 (GLP-2).

Time frame:From -15 minutes to 180 minutes

concentration, descriptive

Other (unclassified)

7 endpoints

Primary/protocol endpoint/low confidence

Relative changes in the plasma levels of C-terminal telopeptide of type I collagen (CTX-1)

Time frame:From -15 minutes to 180 minutes

percent change from baseline, descriptive

componentsauc total, auc incremental baseline subtracted, nadir pct change from baseline

Primary/protocol endpoint/low confidence

Relative changes in the plasma levels of N-terminal propeptide of type I procollagen (P1NP)

Time frame:From -15 minutes to 180 minutes

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Changes in plasma concentrations of glucagon.

Time frame:From -15 minutes to 180 minutes

concentration, descriptive

Secondary/protocol endpoint/low confidence

Changes in plasma concentrations of calcium.

Time frame:From -15 minutes to 180 minutes

concentration, descriptive

Secondary/protocol endpoint/low confidence

Changes in plasma concentrations of parathyroid hormone (PTH)

Time frame:From -15 minutes to 180 minutes

concentration, descriptive

Secondary/protocol endpoint/low confidence

Changes in plasma concentrations of alkaline phosphatase

Time frame:From -15 minutes to 180 minutes

concentration, descriptive

Secondary/protocol endpoint/low confidence

Changes in plasma concentrations of osteocalcin

Time frame:From -15 minutes to 180 minutes

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.